# FDA 483 - Zhejiang Tianyu Pharmaceutical Co. Ltd. - March 04, 2022

Source: https://www.keypedia.com/records/483/zhejiang-tianyu-pharmaceutical-co-ltd/fede0e36-d4f1-4219-bde6-c958d4e5df93

> FDA 483 for Zhejiang Tianyu Pharmaceutical Co. Ltd. on March 04, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Tianyu Pharmaceutical Co. Ltd.
- Inspection Date: 2022-03-04
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: During an FDA inspection from February 28 to March 4, 2022, Zhejiang Tianyu Pharmaceutical Co. Ltd., an API manufacturer, received a Form 483 outlining significant deviations from current Good Manufacturing Practices. The observations centered on critical deficiencies within the firm's quality system and facilities/equipment maintenance. Specifically, the company failed to extend investigations to all potentially impacted batches after discovering an out-of-specification impurity in their (b)(4) API, which led to customer complaints and product returns. Their impurity evaluation procedures were also found inadequate, not thoroughly assessing potential by-products during process development and failing to identify key impurities, leading to distributed non-conforming batches. Furthermore, equipment cleaning and maintenance practices were insufficient. The firm released material without completing cleaning validation, demonstrated inconsistent adherence to cleaning schedules, and FDA investigators observed rust-like and black spots on product-contact surfaces of synthesis equipment. An existing maintenance procedure also lacked instructions for addressing rust. These issues indicate a lack of control over potential contamination risks. Zhejiang Tianyu Pharmaceutical Co. Ltd. is required to implement comprehensive corrective and preventive actions to rectify these serious quality and maintenance deficiencies.

## Related Documents

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- [483 - 2022-03-04](https://www.keypedia.com/records/483/zhejiang-tianyu-pharmaceutical-co-ltd/3388eb23-b206-45a9-b075-915922728724)
- [483 - 2024-11-21](https://www.keypedia.com/records/483/zhejiang-tianyu-pharmaceutical-co-ltd/1a60a15b-bf58-4a25-b4f2-51d949d8d3f9)

## Related Officers

- [Brunilda Torres](https://www.keypedia.com/people/brunilda-torres/44e5068d-d3c4-4228-9d36-24a6ec99214c)
- [Marcus Ray, Consumer Safety Officer](https://www.keypedia.com/people/marcus-ray-consumer-safety-officer/55d8e84f-3042-4593-841b-84999d45bb89)
- [Dennis Cantellops, Consumer Safety Officer](https://www.keypedia.com/people/dennis-cantellops-consumer-safety-officer/797d73b0-7565-4613-9bc0-806091c80008)
- [Laurimer Kuilan-Torres](https://www.keypedia.com/people/laurimer-kuilan-torres/a7f49e33-9d35-4dfe-8bcc-d369d3834ef4)

Company: https://www.keypedia.com/companies/zhejiang-tianyu-pharmaceutical-co-ltd/b7ecf3cd-082c-48b5-94e1-8adeba7ce167

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa